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Of the 56 orthopaedic-related 510(k)s that FDA released in June 2017, I’d like to share some observations on just four:
- Two total hips that we’ve been waiting for: one from ConforMIS and one from Medtronic
- Two spine products: one interbody (SAGICO) and a pedicle screw system (Phamedica)—more on these in a moment.
We’ve been expecting the ConforMIS iTotal hip clearance since the company withdrew its original application and resubmitted it in 2H16. ConforMIS seeks to apply the formula that it uses for knees—complete customization of implants and a reproducible surgical technique—to the hip.
We’ve awaited the Medtronic hip since they acquired Responsive Orthopedics—a startup focused on low-cost hip and knee replacements—about a year ago. The knee has already cleared and launched, but very little light has been shone on uptake of the company’s orthopaedic program, so far. My hope is that this second product clearance and subsequent launch will get some buzz going; leadership has promised to talk about it this year.
Phamedica and SAGICO just received their very first FDA 510(k) clearances, ever, and enter the already-well-populated spine market. Not much information is available yet for Phamedica, though we do know that they were listed among exhibitors at NASS 2015 and that it’s a newer company, founded in 2014. SAGICO is headquartered in the U.K., and of their wide range of spine products available ex-U.S., they now enter the states with an interbody fusion system.
Orthopaedic-related FDA 510(k) Clearances YTD, 2015 to 2017
I mention the number of devices cleared each month because I want to see whether
the volume is going up or down, year over year—we hear about regulatory hurdles and
difficulties and challenges left and right, so…how’s it actually going?
Here’s where we are, so far.
The upper gray portions in 2016 and 2015 show how many devices were cleared by
the orthopaedic panel for those years, overall. The numbers dropped, though
we see that 2017 is a bit ahead of 2016, at the half. I’ll keep you posted.
Hips
ConforMIS | iTotal Hip Replacement System | K162719
Bedford, Massachusetts | conformis.com
- First hip product, limited launch slated for 2019
- Supported by same iFit “Image-to-Implant” technology to manufacture cutting jigs and implants as is used to design custom knees
- iTotal hip employs single-use 3D printed instruments and just-in-time delivery
- Originally submitted hip application in 2015, but in light of an inability to address FDA’s review questions within an allowed review timeframe, withdrew the application and resubmitted in 2H16
Responsive Orthopedics/Medtronic
Total Hip Arthroplasty System
K163585
Columbia City, Indiana medtronic.com
- Second product from Medtronic’s orthopaedic initiative (acquired in 2Q16 and launched in 4Q16); first product was the total knee
- Predicates include DePuy Summit Tapered Hip, Ortho Development Ovation Stem, Smith & Nephew REFLECTION, United Orthopedic U2 Acetabular/UTF Stem/U2 Femoral Head
- While no recent announcement has been made, at the time of acquisition, leadership had noted potential launch of a primary hip in 1H18
- Per FY4Q17 call, expect to hear an update on Medtronic Orthopaedic Solutions this year (next quarterly report is scheduled for 8/22/17)
Spine
Phamedica | PHA S1 Spinal System | K163011
Plainview, New York
- System comprises titanium alloy polyaxial and monoaxial screws and reduction screws, rods, set screws, transverse/offset connectors
Spinal Analytics & Geometrical Implant | SAGICO Interbody Fusion | K161710
London, United Kingdom
- System includes ARIA lumbar and ARION cervical implants made from PEEK (from Invibio), titanium alloy (Dynamet) and tantalum beads/rods (X-medics)
- Per website, company’s full ex-U.S. range includes thoracolumbar fixation, anterior/posterior cervical, interbody fusion, biologics, vertebroplasty/kyphoplasty and cranial products with instrument sets
Sources: FDA 510(k) Releasable Database, company websites, information in the public domain
